Senior Principal Scientist
Department: 400 - Technical Operations / CMC : Cheng Chen/Elise Bradley/Cletus Nunes/Phil Roberts
Employment Type: Full Time
Reference Number: 1691850
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
Why join us?
- The Sr Principal Scientist of Chemical Development will report to the head of Chemical Process R&D or the project leader and will be responsible for the design, development and implementation of robust synthetic processes to support Mirati's small molecule programs with the goal of delivering preclinical and clinical drug substance batches meeting program needs. Individual will be accountable for implementing phase appropriate strategies to develop synthetic processes that comply with regulatory requirements and manufacturing API to support clinical trials, registrational and commercial batches.
- Specific responsibilities will include but are not limited to the following: design and develop viable synthetic routes that are amenable for scale up; managing chemical development of small molecule drug substances, managing timelines for developmental and manufacturing activities performed at CROs and CDMOs, maintaining and authoring all relevant files and reports required for regulatory submissions/health authority inspections/due diligence, and the authoring of the CMC sections of regulatory health authority submissions.
- Lead and manage CRO/CMO activities, define and develop stage appropriate sourcing strategy to meet objectives of Mirati's small molecule drug development programs.
- Carry out chemical process development activities for one or two primary programs and contribute to all other development programs as needed.
- Provide manufacturing oversight for the production of drug substances.
- CMC Regulatory writings to support regulatory submissions as needed.
- Responsible for phase appropriate synthetic route design, practical implementation of synthetic processes and controls for regulatory starting materials, intermediates and drug substances.
- Lead fate and tolerance studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process.
- Lead/support technical transfer of starting material, intermediate or API processes between sites.
- Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers.
- Coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations during production.
- Participate in an interactive, team oriented collaborations with the discovery functions and the tech operation/CMC teams.
- Critically review proposals from CROs or CDMOs; perform appropriate due diligence as needed to ensure CROs and CDMOs can support the requirements of individual chemical development programs effectively.
- Implement risk based approach to development, QbD and DoE principles at appropriate development stages
- Support PAR studies and pre-validation and validation activities for drug substance.
- Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed.
- Build appropriate risk management strategies for chemical development and manufacturing.
- Up to 25% travel will be needed for scientific project management and monitoring of critical project activities
What is Required:
- PhD or MS with >10-15 years of experience in organic chemistry, chemical engineering, and related discipline with relevant drug substance development experience in pharmaceutical and biopharmaceutical industries.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Demonstrated knowledge of drug development, CRO/CDMO management, manufacturing, supply chain management and regulatory CMC.
- Proven ability to develop and implement strategic plans.
- Ability to effectively organize and prioritize tasks to achieve established objectives and deadlines.
- Demonstrated competencies in a core CMC discipline such as drug substance process development, drug substance manufacturing.
- Proven problem solving skills and excellent track record of accomplishments.
- Must possess the ability to effectively manage multiple projects, organize and lead R&D activities.
- Ability to adapt rapidly and change focus based on real time results and findings.
- Exceptional written and verbal communication skills.
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic informations, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.